药品名称QUINIDEX
申请号012796产品号002
活性成分QUINIDINE SULFATE市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格300MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WYETH PHARMACEUTICALS INC
化学类型New dosage form审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
012796049APLetter2002/02/21下载
012796049APLabel2003/05/14下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
012796049AP2001/08/16Labeling Revision
012796048AP1998/06/24Labeling Revision
012796047AP1998/01/13Manufacturing Change or Addition
012796046AP1995/11/09Labeling Revision
012796044AP1988/05/02Package Change
012796043AP1988/02/25Package Change
012796042AP1987/12/01Labeling Revision
012796041AP1987/06/12Labeling Revision
012796040AP1986/04/22Package Change
012796039AP1986/08/12Formulation Revision
012796038AP1988/08/02Labeling Revision
012796037AP1985/07/22Package Change
012796036AP1985/03/07Labeling Revision
012796035AP1985/07/22Control Supplement
012796034AP1984/06/07Package Change
012796033AP1984/05/31Formulation Revision
012796032AP1984/01/04Formulation Revision
012796031AP1984/01/04Package Change
012796030AP1984/01/04Package Change
012796028AP1982/10/26Package Change
012796027AP1982/03/08Formulation Revision
012796023AP1981/12/04Package Change
012796022AP1981/12/04Manufacturing Change or Addition
012796021AP1984/02/22Formulation Revision
012796020AP1980/12/19Package Change
012796019AP1980/12/19Control Supplement
012796018AP1979/06/21Labeling Revision
012796017AP1980/12/19Control Supplement
012796016AP1978/11/07Control Supplement
012796015AP1978/07/20Formulation Revision
012796014AP1977/10/11Control Supplement
012796013AP1977/10/11Control Supplement
012796012AP1977/10/11Formulation Revision
012796011AP1977/10/11General Efficacy (MarkIV)
012796010AP1977/10/11Control Supplement
012796000AP1962/02/21Approval